Common use of Food Safety Clause in Contracts

Food Safety. Except as set forth in Section 4.19 of the Disclosure Schedule, each Acquired Company is and has been in compliance with the applicable provisions of the Federal Food, Drug, and Cosmetic Act, as amended, all applicable U.S. Food and Drug Administration (“FDA”) regulations, and all other applicable federal, state, county or other local Laws relating to the use, manufacture, packaging, licensing, labeling, distribution, testing, storage or sale (collectively, “manufacture,” “manufacturing” or “manufactured” as applicable by context) of any of the Acquired Company’s Products (collectively, “Applicable Food Laws”). Except as set forth in Section 4.19 of the Disclosure Schedule, all Products manufactured by each Acquired Company are and were, at the time of manufacture and at the time of shipment by the Acquired Company: (i) manufactured in accordance with good manufacturing practices (including those set forth in 21 CFR Part 110) and any applicable sanitation requirements, (ii) if required, manufactured in facilities registered with the FDA or any other applicable Governmental Authority, (iii) if a food additive, either Generally Recognized As Safe (GRAS) or subject to a valid and approved food additive petition filed with the FDA, and (iv) not adulterated or misbranded within the meaning of the Applicable Food Laws, in each case in (i)-(iv) above as in effect at such time. Since January 1, 2016, there have been no recalls or withdrawals of any Products manufactured by any Acquired Company, and to the Sellers’ Knowledge, there are no facts that are reasonably likely to cause a recall or withdrawal of any such Products. Except as set forth in Section 4.19 of the Disclosure Schedule, each Acquired Company is not now, and since January 1, 2016 has not been, subject to any warning letter or other written adverse inspection finding, citation or notice of inspectional observation (FDA Form 483), investigation, penalty, assessment (including civil monetary penalties), inspection, or other compliance or enforcement action by any Governmental Authority having responsibility for the regulation of the Products manufactured by the Acquired Company. The Acquired Companies are not subject to any obligation or requirement arising under any injunction, consent decree, consent agreement, inspection report, plea agreement, or warning letter, or other order or agreement issued by or entered into with any United States or foreign Governmental Authority with regard to the development, manufacture, registration, approval, marketing, promotion, advertising, storage or transportation of any Products. The Acquired Companies have not received any written notice or written report from the FDA or any other Governmental Authority having responsibility for the regulation of or jurisdiction over the Products manufactured by the Acquired Company alleging a material violation of or Liability under Applicable Food Laws that is pending or remains unresolved. The Acquired Companies have not made any material false statements or material omissions in any applications or other submissions to the FDA or other Governmental Authorities having responsibility for the regulation of the Acquired Companies’ Products and operations, and have not made or offered any payments, gratuities, or other things of value that are prohibited by Applicable Food Laws or any other Law to personnel of the FDA or other Governmental Authorities.

Food Safety. 3. Except as set forth to matters that would not reasonably be expected to have, individually or in Section 4.19 of the Disclosure Scheduleaggregate, each Acquired Company is a Material Adverse Effect, since January 1, 2014, the Companies and has been all products manufactured, marketed, sold or distributed by the Business (the “Products”) have complied and are in compliance with (%4) the applicable provisions of the Federal Food, Drug, and Cosmetic Act, as amended, all Act and the applicable regulations and requirements adopted by the U.S. Food and Drug Administration (the “FDA”) regulationsthereunder, the applicable statutes, regulations and all other applicable federal, state, county or other local Laws relating to the use, manufacture, packaging, licensing, labeling, distribution, testing, storage or sale (collectively, “manufacture,” “manufacturing” or “manufactured” as applicable by context) of any requirements of the Acquired Company’s Products U.S. Department of Agriculture (collectively, the “Applicable Food LawsUSDA”). Except as set forth in Section 4.19 of the Disclosure Schedule, all Products manufactured by each Acquired Company are and were, at the time of manufacture and at the time of shipment applicable statutes enforced by the Acquired Company: U.S. Federal Trade Commission (i“FTC”) manufactured in accordance with good manufacturing practices (including those set forth in 21 CFR Part 110) and the applicable FTC regulations and requirements and any applicable sanitation requirementsrequirements established by any U.S. state, provincial or local Governmental Authority responsible for regulating food products (ii) if required, manufactured in facilities registered together with the FDA or any other applicable Governmental Authorityand the USDA, (iiicollectively, the “Food Authorities”) if a food additive, either Generally Recognized As Safe (GRAS) or subject to a valid and approved food additive petition filed with the FDA, and (iv%4) all terms and conditions imposed in any Permits granted to any Seller or the Business by any Food Authority. (a) Except as to matters that would not adulterated reasonably be expected to have, individually or misbranded within in the meaning of aggregate, a Material Adverse Effect, or reasonably be expected to materially impair or delay the Applicable Food LawsSellers’ ability to consummate the transactions contemplated hereby, in each case in (i)-(iv) above as in effect at such time. Since the Business has not, since January 1, 20162014, voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement relating to an alleged lack of safety or regulatory compliance of any Product. To the Sellers’ knowledge, there are no facts or circumstances that would cause any Governmental Authority to require the recall or market withdrawal of any Product. (b) Except as to matters that would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, or reasonably be expected to materially impair or delay the Sellers’ ability to consummate the transactions contemplated hereby, since January 1, 2014, there have been no recalls actions, pending, or withdrawals to the knowledge of the Sellers, threatened with respect to a material violation by the Business of any Products manufactured applicable statute or regulation enforced by any Acquired Company, and to the Sellers’ Knowledge, there are no facts that are reasonably likely to cause a recall or withdrawal of any such Products. Except as set forth in Section 4.19 of the Disclosure ScheduleFood Authorities, each Acquired Company is not now, and since January 1, 2016 has not been, subject to any warning letter or other written adverse inspection finding, citation or notice of inspectional observation (FDA Form 483), investigation, penalty, assessment (including civil monetary penalties), inspection, or other compliance or enforcement action by any Governmental Authority having responsibility for the regulation of the Products manufactured by the Acquired Company. The Acquired Companies are not subject to any obligation or requirement arising under any injunction, consent decree, consent agreement, inspection report, plea agreement, or warning letter, or other order or agreement issued by or entered into with any United States or foreign Governmental Authority with regard to the development, manufacture, registration, approval, marketing, promotion, advertising, storage marketing or transportation distribution of any Products. The Acquired Companies have not received any written notice or written report from the FDA or any other Governmental Authority having responsibility for the regulation of or jurisdiction over the Products manufactured by the Acquired Company alleging a material violation of that would be reasonably expected to result in administrative, civil or Liability under Applicable Food Laws that is pending or remains unresolved. The Acquired Companies have not made any material false statements or material omissions in any applications or other submissions to the FDA or other Governmental Authorities having responsibility for the regulation of the Acquired Companies’ Products and operations, and have not made or offered any payments, gratuities, or other things of value that are prohibited by Applicable Food Laws or any other Law to personnel of the FDA or other Governmental Authoritiescriminal liability.

Food Safety. (a) Except as set forth has not resulted in Section 4.19 of and would not reasonably be expected to result in, individually or in the Disclosure Scheduleaggregate, each a Material Adverse Effect, since January 1, 2016, the Acquired Company is Entities have complied and has been are in compliance with (i) the applicable provisions of the Federal Food, Drug, and Cosmetic Act, as amended, all Act and the applicable regulations and requirements adopted by the U.S. Food and Drug Administration (the “FDA”) regulationsthereunder, the applicable statutes, regulations and requirements of the U.S. Department of Agriculture (the “USDA”), all other applicable federal, statutes enforced by the FTC and the applicable FTC regulations and requirements and any applicable requirements established by any state, county local or other local Laws relating foreign Governmental Authority responsible for regulating food products (together with the FDA and the USDA, collectively, the “Food Authorities”) and (ii) all terms and conditions imposed in any Permits granted to the use, manufacture, packaging, licensing, labeling, distribution, testing, storage or sale Acquired Entities by any Food Authority. (collectively, “manufacture,” “manufacturing” or “manufactured” as applicable by contextb) of any of the Acquired Company’s Products (collectively, “Applicable Food Laws”). Except as (i) set forth in Section 4.19 2.20(b) of the Seller Disclosure Schedule, all Products manufactured by each Acquired Company are and were, at the time of manufacture and at the time of shipment by the Acquired Company: (i) manufactured in accordance with good manufacturing practices (including those set forth in 21 CFR Part 110) and any applicable sanitation requirements, Schedule or (ii) if required, manufactured in facilities registered with the FDA or any other applicable Governmental Authority, (iii) if a food additive, either Generally Recognized As Safe (GRAS) or subject to a valid and approved food additive petition filed with the FDAhas not resulted in, and would not reasonably be expected to result in, individually or in the aggregate, a Material Adverse Effect: (iv1) not adulterated or misbranded within the meaning of the Applicable Food Laws, in each case in (i)-(iv) above as in effect at such time. Since since January 1, 2016, no Acquired Entity has voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement relating to an alleged lack of safety or regulatory compliance of any product (excluding, for the avoidance of doubt, compliance with recalls initiated by a third party), and (2) there have has been no recalls presence, release or withdrawals exposure to any food contaminants or adulterants, food poisoning, pests, mold or microbial agents due to any Acquired Entity’s noncompliance with Food Safety Laws, and there has not been any facility shutdown or other food-related condition with respect to the business or products of any Products manufactured by Acquired Entity, in each case, that has given or would give rise to any liability or obligation of any Acquired Company, and to the Sellers’ Knowledge, there are no facts that are reasonably likely to cause a recall or withdrawal of any such Products. Except as set forth in Section 4.19 of the Disclosure Schedule, each Acquired Company is not now, and since January 1, 2016 has not been, subject to any warning letter or other written adverse inspection finding, citation or notice of inspectional observation (FDA Form 483), investigation, penalty, assessment (including civil monetary penalties), inspection, or other compliance or enforcement action by any Governmental Authority having responsibility for the regulation of the Products manufactured by the Acquired Company. The Acquired Companies are not subject to any obligation or requirement arising Entity under any injunction, consent decree, consent agreement, inspection report, plea agreement, or warning letter, or other order or agreement issued by or entered into with any United States or foreign Governmental Authority with regard to the development, manufacture, registration, approval, marketing, promotion, advertising, storage or transportation of any Products. The Acquired Companies have not received any written notice or written report from the FDA or any other Governmental Authority having responsibility for the regulation of or jurisdiction over the Products manufactured by the Acquired Company alleging a material violation of or Liability under Applicable Food Laws that is pending or remains unresolved. The Acquired Companies have not made any material false statements or material omissions in any applications or other submissions to the FDA or other Governmental Authorities having responsibility for the regulation of the Acquired Companies’ Products and operations, and have not made or offered any payments, gratuities, or other things of value that are prohibited by Applicable Food Laws or any other Law to personnel of the FDA or other Governmental AuthoritiesSafety Laws.

Food Safety. (a) Except as set forth has not resulted in Section 4.19 of and would not reasonably be expected to result in, individually or in the Disclosure Scheduleaggregate, each a Material Adverse Effect, since June 1, 2021, the Acquired Company is Entities have complied and has been are in compliance with (i) the applicable provisions of the Federal Food, Drug, and Cosmetic Act, as amended, all Act and the applicable regulations and requirements adopted by the U.S. Food and Drug Administration (the “FDA”) regulationsthereunder, the applicable statutes, regulations and requirements of the U.S. Department of Agriculture (the “USDA”), all applicable statutes enforced by the U.S. Federal Trade Commission (the “FTC”) and the applicable FTC regulations and requirements and any applicable requirements established by any state, local or foreign Governmental Authority responsible for regulating food products (together with the FDA and the USDA, collectively, the “Food Authorities”) and (ii) all terms and conditions imposed in any Permits granted to the Acquired Entities by any Food Authority. (b) Except as has not resulted in, and all other applicable federalwould not reasonably be expected to result in, stateindividually or in the aggregate, county or other local Laws relating to the use, manufacture, packaging, licensing, labeling, distribution, testing, storage or sale (collectively, “manufacture,” “manufacturing” or “manufactured” as applicable by context) of any of the Acquired Company’s Products (collectively, “Applicable Food Laws”). Except as set forth in Section 4.19 of the Disclosure Schedule, all Products manufactured by each Acquired Company are and were, at the time of manufacture and at the time of shipment by the Acquired Companya Material Adverse Effect: (i) manufactured in accordance since June 1, 2021, no Acquired Entity has voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement relating to an alleged lack of safety or regulatory compliance of any product (excluding, for the avoidance of doubt, compliance with good manufacturing practices (including those set forth in 21 CFR Part 110recalls initiated by a third party) and any applicable sanitation requirements, (ii) if requiredthere has been no presence, manufactured in facilities registered release or exposure to any food contaminants or adulterants, food poisoning, pests, mold or microbial agents due to any Acquired Entity’s noncompliance with the FDA or any other applicable Governmental Authority, (iii) if a food additive, either Generally Recognized As Safe (GRAS) or subject to a valid and approved food additive petition filed with the FDAFood Safety Laws, and (iv) there has not adulterated been any facility shutdown or misbranded within other food-related condition with respect to the meaning business or products of the Applicable Food Lawsany Acquired Entity, in each case in (i)-(iv) above as in effect at such time. Since January 1case, 2016, there have been no recalls that has given or withdrawals would give rise to any liability or obligation of any Products manufactured by any Acquired Company, and to the Sellers’ Knowledge, there are no facts that are reasonably likely to cause a recall or withdrawal of any such Products. Except as set forth in Section 4.19 of the Disclosure Schedule, each Acquired Company is not now, and since January 1, 2016 has not been, subject to any warning letter or other written adverse inspection finding, citation or notice of inspectional observation (FDA Form 483), investigation, penalty, assessment (including civil monetary penalties), inspection, or other compliance or enforcement action by any Governmental Authority having responsibility for the regulation of the Products manufactured by the Acquired Company. The Acquired Companies are not subject to any obligation or requirement arising Entity under any injunction, consent decree, consent agreement, inspection report, plea agreement, or warning letter, or other order or agreement issued by or entered into with any United States or foreign Governmental Authority with regard to the development, manufacture, registration, approval, marketing, promotion, advertising, storage or transportation of any Products. The Acquired Companies have not received any written notice or written report from the FDA or any other Governmental Authority having responsibility for the regulation of or jurisdiction over the Products manufactured by the Acquired Company alleging a material violation of or Liability under Applicable Food Laws that is pending or remains unresolved. The Acquired Companies have not made any material false statements or material omissions in any applications or other submissions to the FDA or other Governmental Authorities having responsibility for the regulation of the Acquired Companies’ Products and operations, and have not made or offered any payments, gratuities, or other things of value that are prohibited by Applicable Food Laws or any other Law to personnel of the FDA or other Governmental AuthoritiesSafety Laws.

Food Safety. (a) Except as set forth to matters that would not reasonably be expected to have, individually or in Section 4.19 the aggregate, a Material Adverse Effect, since January 1, 2015, the Companies and all products manufactured, marketed, sold or distributed by the Companies (the “Products”) have complied and are in compliance, to the extent within the control of the Disclosure ScheduleCompanies, each Acquired Company is and has been in compliance with (i) the applicable provisions of the Federal Food, Drug, and Cosmetic Act, as amended, all Act and the applicable regulations and requirements adopted by the U.S. Food and Drug Administration (the “FDA”) regulationsthereunder, the applicable statutes, regulations and requirements of the U.S. Department of Agriculture (the “USDA”), all applicable statutes enforced by the U.S. Federal Trade Commission (“FTC”), the applicable FTC regulations and requirements and any Applicable Law or other applicable federal, requirements established by any state, county local or other local Laws relating to foreign Governmental Authority responsible for regulating food products or the usemanufacture, manufactureproduction, packaging, licensinglabeling, labelingtransportation, distribution, testingsale or marketing thereof (such Applicable Laws, storage or sale (regulations and other requirements, together with the Federal Food, Drug, and Cosmetic Act, collectively, the “manufacture,” “manufacturing” or “manufactured” as applicable by context) of any of Food Safety Laws”; such Governmental Authorities, together with the Acquired Company’s Products (FDA and the USDA, collectively, the “Applicable Food LawsAuthorities”). ) and (ii) all terms and conditions imposed in any Permits granted to the Companies by any Food Authority. (b) Except as set forth would not, individually or in Section 4.19 of the Disclosure Scheduleaggregate, all Products manufactured by each Acquired Company are and werereasonably be expected to have a Material Adverse Effect, at the time of manufacture and at the time of shipment by the Acquired Company: since January 1, 2015, (i) manufactured in accordance no Company has, voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement relating to an alleged lack of safety or regulatory compliance of any Product (excluding, for the avoidance of doubt, compliance with good manufacturing practices (including those set forth in 21 CFR Part 110) recalls initiated by a third party), and any applicable sanitation requirements, (ii) if requiredthere has been no presence, manufactured in facilities registered release of or exposure to any food contaminants or adulterants, food poisoning, pests, mold or microbial agents due to any Company’s noncompliance with Food Safety Laws, nor any facility shutdowns or other food-related conditions with respect to the FDA business or Products of any other applicable Governmental Authority, (iii) if a food additive, either Generally Recognized As Safe (GRAS) or subject to a valid and approved food additive petition filed with the FDA, and (iv) not adulterated or misbranded within the meaning of the Applicable Food LawsCompany, in each case in (i)-(iv) above as in effect at such time. Since January 1, 2016, there have been no recalls that has given or withdrawals would give rise to any liability or obligation of any Products manufactured by any Acquired Company, and to the Sellers’ Knowledge, there are no facts that are reasonably likely to cause a recall or withdrawal of any such Products. Except as set forth in Section 4.19 of the Disclosure Schedule, each Acquired Company is not now, and since January 1, 2016 has not been, subject to any warning letter or other written adverse inspection finding, citation or notice of inspectional observation (FDA Form 483), investigation, penalty, assessment (including civil monetary penalties), inspection, or other compliance or enforcement action by any Governmental Authority having responsibility for the regulation of the Products manufactured by the Acquired Company. The Acquired Companies are not subject to any obligation or requirement arising under any injunction, consent decree, consent agreement, inspection report, plea agreement, or warning letter, or other order or agreement issued by or entered into with any United States or foreign Governmental Authority with regard to the development, manufacture, registration, approval, marketing, promotion, advertising, storage or transportation of any Products. The Acquired Companies have not received any written notice or written report from the FDA or any other Governmental Authority having responsibility for the regulation of or jurisdiction over the Products manufactured by the Acquired Company alleging a material violation of or Liability under Applicable Food Laws that is pending or remains unresolved. The Acquired Companies have not made any material false statements or material omissions in any applications or other submissions to the FDA or other Governmental Authorities having responsibility for the regulation of the Acquired Companies’ Products and operations, and have not made or offered any payments, gratuities, or other things of value that are prohibited by Applicable Food Laws or any other Law to personnel of the FDA or other Governmental AuthoritiesSafety Laws.